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Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)

NCT05374915 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-08-28

No results posted yet for this study

Summary

This is an open-label, single cohort study to confirm dose, assessments and timing of response, to support future studies. The primary objective of the trial is to evaluate cutaneous tumor response within total target treatment field to REM-001 therapy assessed using standardized digital photography

Conditions

  • Cutaneous Breast Cancer

Interventions

COMBINATION_PRODUCT

REM-001 photodynamic therapy

Infusion of REM-001 (iv) followed by light treatment to treatment field 24 hrs after infusion of REM-001

Sponsors & Collaborators

  • Kintara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Alina Markova, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2025-12-30
Completion
2025-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05374915 on ClinicalTrials.gov